The Effect of Patient Education and Rehabilitation on Quality of Life in Patients With Permanent Stomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Kjærgaard Danielsen, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01154725
First received: June 30, 2010
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

The purpose of the experiment is to study the effect it has on patients' quality of life if they go through a structured process marked by intensified and specialized effort by ostomy nurse. This includes close monitoring during hospitalization, telephone contact and guidance following discharge and participation in a group based patient school up to 4 months after discharge .

At the same time the study also examines what the economic effect of following the intervention will have.


Condition Intervention
Colostomy
Behavioral: Patient education and rehabilitation
Behavioral: habitual patient education

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Patient Education and Rehabilitational Interventions on Health Related Quality of Life of Patients With Permanent Stomas Regardless of Cause

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Ostomy Adjustment Scale measurement of quality of life [ Time Frame: 6 months (+/- 2 weeks) postoperatively ] [ Designated as safety issue: No ]
    the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.


Secondary Outcome Measures:
  • Economic effect [ Time Frame: 6 months after discharge ] [ Designated as safety issue: No ]
    The investigators will monitor readmittance and contacts and diagnostic procedures and therapeutic interventions related to stoma creation during the period from admittance to hospital until 6 months after discharge.

  • Ostomy Adjustment Scale and SF-36 measurement of quality of life [ Time Frame: 3 months (+/-2 weeks) postoperatively ] [ Designated as safety issue: No ]
    the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.

  • Ostomy Adjustment Scale and SF-36 measurement of quality of life [ Time Frame: 3-7 days postoperatively before discharge ] [ Designated as safety issue: No ]
    the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.

  • SF-36 measurement of quality of life [ Time Frame: 6 months (+/- 2 weeks) postoperatively ] [ Designated as safety issue: No ]
    the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.


Enrollment: 50
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Habitual stoma care
habitual patient education
Behavioral: habitual patient education
habitual patient education
Experimental: Patient education and rehabilitation
patient education and rehabilitation
Behavioral: Patient education and rehabilitation
Patients in the experimental group will receive specialized and optimized care by stoma care nurses. This includes one-on-one guiding during the hospitalization, guidance by telephone after discharge and participation in patient education 3 times after discharge.
Other Names:
  • health related quality of life
  • patient education
  • stoma care
  • stomatherapy
  • telephone guidance
  • group based learning

Detailed Description:

Construction of an ostomy is a radical treatment with permanent physical signs of body alteration. It leads to loss of a central and very personal bodily function (excretion of faeces through the rectum) and there is a significant change in personal hygiene.

Having a colostomy is not a uniform state but is characterized by many different factors: Several types of ostomy, several underlying causes that lead to stoma creation such as cancer, several individual psychosocial profile, which naturally affect individuals differently. Patients are forced to living with a changed body image, a change in daily routines, and for some there will also be changes in lifestyle, social standing and their sexuality will be affected. At the same time patients experience a break when they are discharged from the hospital, and they may lack the practical and emotional support.

The training and education of patients is increasingly being carried out by stoma nurses both in Denmark and internationally. The primary role is to inform and prepare patients before surgery and to keep the contact with patients after surgery to ensure the fulfillment of the patient´s independent and meaningful life after ostomy construction. It is assumed that ostomy nurse's intervention and involvement are important for the patient's quality of life, but there are no studies that uniquely identifies the type of education that has the greatest effect, which applies both to content and methods.

Quality of life measurement in health care is a merging method to ensure the patient´s perspective on health treatments.It is greatly needed to test the efficacy of nursing interventions on patients' quality of life. Pressure on health services increase which makes it imperative also to include analysis and calculation of economic effect of the intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • All patients with permanent or temporary stomas regardless of cause that are expected to be able to cooperate in filling out questionnaires and who will participate in the planned interventions.

Exclusion criteria:

  • Patients that post-operatively are not able to cooperate and participate in the planned interventions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154725

Locations
Denmark
Herlev University Hospital
Herlev, Denmark, 2730
Department of Surgery, Herlev University Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Anne K Danielsen, Nurse, MaClN Herlev University Hospital, Department of Gastroenterology
  More Information

No publications provided by Herlev Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Kjærgaard Danielsen, Ph.d.student, RN, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01154725     History of Changes
Other Study ID Numbers: AKD01
Study First Received: June 30, 2010
Last Updated: December 11, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
Patient education
Health-Related Quality of Life
patients with stomas
stomatherapy
health economics

ClinicalTrials.gov processed this record on September 22, 2014